510(k) · Cleared
ClearedIdeal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ideal Life, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 14, 2006 as substantially equivalent to K021682 (Omron Healthcare, Inc., 2002) and 2 other predicates after a 15-day review. Its family tree reaches back 6 generations to 1987. 5 later devices descend from it.
- Decided
- Mar 14, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K864318 (1987). 17 ancestors in all, the oldest K790130 (1979). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 4 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 3 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 2 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 1 generation backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- This deviceK060504 Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001Ideal Life, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK080538 Ideal Life Pod (Model Ilp 0001)Ideal Life, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK111932 Iglucose SystemPositiveid Corporation · 2011
- Descendant · 3 generations on · 1 of its ownK130676 Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health · 2013
- Descendant · 4 generations on · 0 of its ownK132148 S HealthSamsung Electronics Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK100524 Polytel (R) Apt Model: Pwa-08-01Polymap Wireless, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K080538Ideal Life Pod (Model Ilp 0001)Ideal Life, Inc. · 2008 · cites it directly4descendants
- K111932Iglucose SystemPositiveid Corporation · 2011 · 2 generations on2descendants
- K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health · 2013 · 3 generations on1descendant
- K132148S HealthSamsung Electronics Co., Ltd. · 2013 · 4 generations on0descendants
- K100524Polytel (R) Apt Model: Pwa-08-01Polymap Wireless, LLC · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −5 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −4 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −3 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −2 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −1 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| 0 (this device) | K060504 | Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001 | Ideal Life, Inc. | 2006 | — |
| +1 | K080538 | Ideal Life Pod (Model Ilp 0001) | Ideal Life, Inc. | 2008 | — |
| +2 | K111932 | Iglucose System | Positiveid Corporation | 2011 | — |
| +3 | K130676 | Ambio Remote Health Monitoring System | Arrayent Health, LLC D/B/A Ambio Health | 2013 | — |
| +4 | K132148 | S Health | Samsung Electronics Co., Ltd. | 2013 | — |
| +2 | K100524 | Polytel (R) Apt Model: Pwa-08-01 | Polymap Wireless, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021682 | Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773, Hem-773ACSummary page 2…anel: Circulatory System Devices 3 PREDICATE DEVICES I. Omron Automatic Blood Pressure Monitor with IntellisenseTM, Model HtEM- 773AC (K021682), 2. IN TOUCHF® Diabetes Management Software System, K984527; and 3. Carematix Wellness System, K031840. 4 DESCRIPTION… | 2002 |
| * | K984527 | IN Touch Diabetes Management SoftwareSummary page 2…TE DEVICES I. Omron Automatic Blood Pressure Monitor with IntellisenseTM, Model HtEM- 773AC (K021682), 2. IN TOUCHF® Diabetes Management Software System, K984527; and 3. Carematix Wellness System, K031840. 4 DESCRIPTION OF THE DEVICES The IDEAL LIFE BP-MANAGERT M is a single unit sof… | 1999 |
| * | K031840 | Carematix Wellness SystemSummary page 2…re Monitor with IntellisenseTM, Model HtEM- 773AC (K021682), 2. IN TOUCHF® Diabetes Management Software System, K984527; and 3. Carematix Wellness System, K031840. 4 DESCRIPTION OF THE DEVICES The IDEAL LIFE BP-MANAGERT M is a single unit software-controlled device with a blood pressure c… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080538 | Ideal Life Pod (Model Ilp 0001) | 2008 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K080538 (Ideal Life, Inc., 2008) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K021682.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The IDEAL LIFE BP-MANAGERTM is a non-invasive blood pressure monitor intended for the measurement of systolic and diastolic blood pressure and heart rate (pulse rate) using the oscillometric- technique. The IDEAL LIFE BP-MANAGERTM should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BPMANAGER TM should not be used on infants or children. The end user of this device should not have…
Read the full statement (213 words)
The IDEAL LIFE BP-MANAGERTM is a non-invasive blood pressure monitor intended for the measurement of systolic and diastolic blood pressure and heart rate (pulse rate) using the oscillometric- technique. The IDEAL LIFE BP-MANAGERTM should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BPMANAGER TM should not be used on infants or children. The end user of this device should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience arte required for interpretation of information. This device is not intended as a substitute for medical care.
The IDEAL LIFE PODTM is an optional accessory to the IDEAL LIFE BPMANAGER TM and is a transmitter that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGERTM to the internet via common telephone lines from the user's home setting. The IDEAL LIFE PODTM is an optional accessory designed to assist in the management of user information. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check or interpret information transmitted. This device is not intended as a substitute for medical care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060504: Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060504
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026